A Phase 3, Observer-Blinded, Randomized, Active-Controlled (Engerix-B), Multicenter Trial of the Safety and Immunogenicity of HEPLISAV in Adults 18 to 70 Years of Age
Phase of Trial: Phase III
Latest Information Update: 09 Nov 2017
At a glance
- Drugs V 270 (Primary) ; Hepatitis B vaccine recombinant
- Indications Hepatitis B
- Focus Adverse reactions; Pharmacodynamics; Registrational
- Sponsors Dynavax Technologies
- 09 Nov 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has approved HEPLISAV-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.
- 03 Apr 2017 According to a Dynavax Technologies media release, the U.S. Food and Drug Administration (FDA) has informed the company that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will review HEPLISAV-B™ at its meeting scheduled for July 28, 2017. The scheduled VRBPAC meeting is close to the HEPLISAV-B Prescription Drug User Fee Act date of August 10, 2017 solely as a function of meeting logistics. The PDUFA date remains unchanged.
- 26 Oct 2016 Sub-group results published in the Dynavax Media Release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History